Guideline on medicines for the treatment of irritable bowel syndrome released for a six-month public consultation

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19/07/2013

Guideline on medicines for the treatment of irritable bowel syndrome released for a six-month public consultation

The European Medicines Agency has released a draft guideline on the clinical investigation of medicines for the treatment of irritable bowel syndrome for a six-month public consultation.

Comments should be made using the submission form and sent no later than 15 January 2014 to gastroenterologydg@ema.europa.eu.

The proposed guideline will replace the existing points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome. The main changes cover:

  • the criteria to be used for patient selection in clinical trials (from Rome II to Rome III criteria) and the introduction of more flexibility with regard to disease classification;
  • new recommendations on primary endpoints to be used in confirmatory clinical trials;
  • dedicated chapters on subgroups of patients (male / female, children and the elderly) and on patients’ geographical origin.

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